Reliability of the Human Brain Connectome (NCT02193425) | Clinical Trial Compass
CompletedEarly Phase 1
Reliability of the Human Brain Connectome
United States112 participantsStarted 2015-06-08
Plain-language summary
Background:
\- Magnetic resonance imaging (MRI) is used to investigate brain function. Researchers want to use MRI to better understand the function patterns and connections between brain regions in healthy people. This might help people with brain diseases in the future.
Objectives:
* To evaluate MRI methods performed twice on the same day.
* To evaluate brain function using positron emission tomography (PET).
Eligibility:
\- Healthy volunteers at least 18 years old.
Design:
* Visit 1:
* Participants will be screened with medical history, physical exam, and interview about drug and alcohol use and psychiatric history.
* They will give blood and urine samples. Their breath will be tested for alcohol and smoking.
* Visit 2:
* Participants will have urine collected. They will have MRI scans, some while resting, some while doing tasks on a computer.
* The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder, with a coil over their head. Participants will get earplugs for loud noises.
* Visit 3:
* Participants will have urine collected.
* A needle will guide a thin plastic tube (catheter) into each arm. The needle will be removed, leaving the catheter in the vein.
* Participants will then have a PET scan. They will get the chemical 18FDG in the catheter. They will lie on a bed that slides in and out of the PET scanner, with a cap on their head.
* Participants may have tests of memory, attention, concentration, and thinking. They may complete interviews, questionnaires, tests on paper or computer, and simple actions.
* Participants will wear a device for 1 week between visits to measure activity and sleep.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
All Participants:
* Older than 18 years of age.
* Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent
EXCLUSION CRITERIA:
* Pregnant or breast feeding. Females of childbearing potential must have negative urine pregnancy test and not be currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy) females satisfy these criteria.
* The following current chronically used (within 2 months of study procedures) psychoactive medications or medications that can affect brain function (including but not limited to meperidine, tricyclic antidpressants, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs), stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil); opioid analgesics; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antihistamines (sedating); beta blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics
(benzodiazepine or barbiturates); lithium; muscle relaxants, and systemic steroids as determined by history and clinical exam.
* Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder as determined by history and clinical exam including substance use disorder (except for nicotine/caffeine), alcoholism…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The overarching goal of this study is to quantify the reproducibility of multiple measures of brain functional connectivity (FC) during resting conditions and during task performance.
Timeframe: end of study
Trial details
NCT IDNCT02193425
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)